FDA applicant
Carol Cole Company Dba Nuface
FDA records 8 decisions for Carol Cole Company Dba Nuface (Vista, CA) from 2017 to 2024: 8 510(k) clearances. Most are in product codes NFO (Stimulator, Transcutaneous Electrical…) and OHS (Light Based Over The Counter Wrinkle Reduction). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Carol Cole Company Dba Nuface®”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Carol Cole Company Dba Nuface’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Carol Cole Company Dba Nuface’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Carol”
FDA records each applicant name separately; these may or may not be the same firm.